GJA — Test, Thrombin Time Class II
FDA Device Classification
Classification Details
- Product Code
- GJA
- Device Class
- Class II
- Regulation Number
- 864.7875
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K050817 | r2 diagnostics | T-TEK | December 12, 2005 |
| K982209 | sigma diagnostics | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | October 15, 1998 |
| K970645 | behring diagnostics | BC THROMBIN REAGENT | May 19, 1997 |
| K925493 | biomerieux vitek | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | April 21, 1994 |
| K930157 | behring diagnostics | TEST THROMBIN | May 14, 1993 |
| K923220 | medical laboratory automation systems | THROMBIN CLOT TIME TEST PROCEDURE | September 29, 1992 |
| K920147 | helena laboratories | THROMBIN CLOTTING TIME REAGENT | May 1, 1992 |
| K900126 | international technidyne | TT AND HNTT BY HEMOCHRON | February 5, 1990 |
| K894467 | sigma chemical | THROMBIN TIME REAGENT | September 5, 1989 |
| K884385 | american bioproducts | FIBRI-PREST/THROMBIN-PREST CONTROLS | December 28, 1988 |
| K884384 | american bioproducts | THROMBIN-PREST REAGENT KIT | December 28, 1988 |
| K862301 | instrumentation laboratory | IL SYSTEM 810, ACL AND THE REAGENT SETS | September 3, 1986 |
| K845000 | bio/data | THROMBINEX BOVINE THROMBIN | March 26, 1985 |
| K841956 | haemachem | BOVINE THROMBIN, HUMAN THROMBIN | July 19, 1984 |
| K834301 | bio/data | THROMBOLYTIC ACTIVITY TEST | February 4, 1984 |
| K822466 | american dade | THROMBIN TIME TEST | September 14, 1982 |
| K811109 | bio/data | THROMBIN CLOTTING TIME | July 16, 1981 |
| K802117 | general diagnostics | FIBRI QUIK | September 26, 1980 |
| K800926 | general diagnostics | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | May 8, 1980 |
| K781781 | general diagnostics | HEPARSORB | January 10, 1979 |